注射用水PQ3的取样

lovetaom

最近在做注射用水PQ3取样方案时，查到FDA高纯水检查指南和USP42-1231及ISPE第四卷水系统，明确提到注射用水在PQ3阶段，应该至少每daily在系统的某处进行取样，每周轮换一次，联系上下文，请问这个daily是每个工作日呢还是每个自然日（按我的理解是每个自然日）？因为公司日后需要过国外GMP，所以需要搞明白，希望英语高手和药政高手帮忙回答，谢谢！
USP42-1231原文如下： 6.4.4 WATER FOR INJECTION DISTRIBUTION SYSTEM SAMPLING The sampling plans for Water for Injection distribution systems (as well as any water system where some level of bacterial endotoxin control is needed) utilize the same general sampling approaches as do Purified Water systems. However, the regulatory expectations for Water for Injection distribution system sampling plans are more prescriptive because microbial control must be much more stringent as it is related to the bacterial endotoxin attribute. In general, water sampling for microbial and bacterial endotoxin testing is expected to occur daily somewhere in the system, with each outlet being sampled periodically, based on a risk assessment, to characterize the quality of the water.


6.4.4注射用水分配系统采样用水注射用水分配系统（以及需要一定水平细菌内毒素控制的任何供水系统）的抽样计划均采用与纯净水系统相同的通用采样方法。 但是，由于对微生物的控制必须与细菌内毒素属性相关，因此对微生物的控制必须更加严格，因此对注射用水分配系统采样计划的监管期望更加规范。 通常，用于微生物和细菌内毒素测试的水采样预计每天在系统中的某处进行，每个出口都基于风险评估定期进行采样，以表征水质。


ISPE第四卷水系统原文如下：
10.3.3 Phase 3  The third phase is intended to demonstrate that, when operated for an extended time period (typically one year), the system produces and delivers water of the required quality, despite possible seasonal variations of the feed water. Sample locations, frequencies, and test requirements are based on the established procedures. For WFI systems, the FDA Guide recommends sampling daily from a minimum of one point of use, with all points of use tested weekly. At the end of this phase (i.e., after a full year of testing), the validation is considered completed. In most cases, ongoing monitoring will establish a continuing record of water quality.
10.3.3 第三阶段 第三阶段目的是证明，在延长操作期（通常是一年），尽管存在可能因季节变化而引起的给水变化，系统仍能生产并输送出满足质量要求的水。取样位点、频率和检测规格是以已建立的规程为基础的。对于注射用水系统，FDA 指南建议至少每天要从一个用点取样，在一周之内将所有的用点都取到。在该阶段的结束时（如，检测一年以后），就认为验证已经完成了。多数情况下，进行的监控将建立一份水质的持续记录。

FDA高纯水检查指南原文如下：
[size=14.6667px]The third phase of validation is designed to demonstrate that when the water system is operated in accordance with the SOPs over a long period of time it will consistently produce water of the desired quality. Any variations in the quality of the feedwater that could affect the operation and ultimately the water quality will be picked up during this phase of the validation. Sampling is performed according to routine procedures and frequencies. For Water for Injection systems the samples should be taken daily from a minimum of one point of use, with all points of use tested weekly. The validation of the water system is completed when the firm has a full years worth of data.
[size=14.6667px]第三阶段的验证被设计用于证明当按SOPs 操作时，系统在很长时期内能持续生产出所设计质量的用水。在本验证阶段中，进水质量的任何变化都会影响系统的运行并且最终的水质将将被检出。取样按照例行 规程和频率进行。注射用水系统每天至少取样一个使用点，每周对所有使用点应进行取样。当公司有一套数年的有价值的数据时，水系统的验证就完成了。

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hhhy

我认为如果周末不生产，就每个工作日即可